Status:
COMPLETED
Food Effect Study of a Single Dose of ZD4054 (Zibotentan)
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to assess the effect of food on the pharmacokinetics of a 10 mg single oral dose of ZD4054 (Zibotentan)
Eligibility Criteria
Inclusion
- BMI between 18 and 30 kg/m2
- Medical and surgical history and physical examination without any clinically significant findings
- Able to consume standard FDA specified high-fat breakfast.
Exclusion
- Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan
- Medical diagnosis of migraine with an attack during the 12 months prior to Screening
- Use of prescription medication within 2 weeks before dosing
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00710047
Start Date
June 1 2008
End Date
August 1 2008
Last Update
November 15 2010
Active Locations (1)
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1
Research Site
Harrow, United Kingdom